Good

Documentation Practices
(GDP)
TRN-NMD-0018-00R01
 Introduction/Overview
• Documentation Practices Training will cover:
• What is GDP
• FDA expectations
• Signatures & Initials
• Documentation of Data/Record Keeping
• Data Consistency
• Changes/Error corrections
• Documentation /Record-Keeping Don’ts
 WHAT IS GDP?
• Practice for ensuring Documentation and Data Integrity Requirements
are met.

• Includes the proper and consistent method for entering data, signing
documents, making corrections and / or changes to documents per
current ISO and FDA’s Current Good Manufacturing Practices (cGMP)
/ Quality System Regulations (QSR).

• Following GDP is the responsibility of all associates at all levels!

 FDA’s Top 10 List for Documentation
Expectations
1. Legal evidence
2. Permanent record
3. Clear
4. Legible
5. Complete
6. Accurate
7. Real-time records
8. Consistent
9. Records events sequentially
10. Reviewed and approved by those responsible and accountable
 FDA’s Three Golden Rules on Proper
Documentation
1. If it isn’t written down, it didn’t happen.

2. If it isn’t written down correctly, it didn’t happen either.

3. Don’t forget Rules 1& 2!!!!!

 Signatures and Initials
• Signatures are incomplete without the correct date.
• No associate may sign by using another associate’s name.
• Designated alternates within the same function are acceptable
when properly documented and authority granted (via
documented authorization (e.g. email stating the granting of
authority, attached to final signed document)
• Designee signature will consist of his or her signature followed
by the word “for” with the printed name of the person
responsible for the original actions or events and ends with the
current date.
• Example: Jane Doe for Joe Smith on 08-Jun-2016
 Signatures and Initials
• Signatures & Initials are legally binding and represent one of
the following:
• Action = You have performed an activity according to the
specified requirements (GOP, OPS, QLP, etc) such as
manufacture, testing, disposition of material, etc.

• Review/Approval = You accept that the document you are

signing is correct and complete according to the specified
requirements.
 Documentation of Data/Record Keeping
Good Documentation is the “PROOF of What You Do”
“Data” - Information organized for analysis or used for the basis
for making a decision that are the result of original observations
and activities of an activity and are necessary for the
reconstruction and evaluation of the report of that activity.
Examples:
• Travelers,
• Test data sheets,
• RI records,
• FGI logs,
• ECs,
• AARs,
• etc
 Documentation of Data/Record Keeping
All data generated* shall be:
• recorded directly, promptly, and legibly in permanent ink or electronically.
• dated on the date of entry and signed or initialed by the person entering the
data.
• sufficiently detailed to allow reconstruction of the activity so that such
reconstruction is capable of generating SIMILAR RESULTS and
CONCLUSIONS.

Test data/results (pertaining to the study acceptance criteria) shall be accurately

recorded in the applicable data sheet.
• Observations (not pertaining to the acceptance criteria) shall be recorded on a
separate data sheet or project note for further investigation.

* Data generated during the conduct of manufacturing or testing activity purely for the purposes of exploration/
feasibility (Advanced R&D) may be exempted from these requirements provided that any activity pertinent to a DHF
or DMR is later repeated and formally documented as described.
 Documentation of Data/Record Keeping
• Make entries directly into appropriate study record
• For hand-written records:
• Use a black or blue ink ball-point pen
• Do not use pencil/colored ink other than black or blue.
• Do not use felt tip (water soluble) pens
• Securely affix loose papers into notebooks / auxiliary files
• Label entry with the pertinent information (i.e. project #,
etc.)
• Sign/date lab/production records daily as work progresses
• All empty or blank spaces must be marked with a diagonal
line, and ‘N/A’, or “grayed-out” (for electronic documents)
 Documentation of Data/Record Keeping
Arrows or quotation marks to indicate repeated information
are not acceptable.
Each cell should be filled or stricken with N/A as described

Example:
J. Doe 08-10-06 J. Smith 08-04-06
“ “  
J. Doe 08-10-05 J. Smith 08-04-06
 Data Consistency
Date Format
• What date is 12/02/16? Feb 12 or December 2?
• Due to working with Europe, date must include alpha
characters for the month.
• Day should be 2 characters 01,02, etc
• Year can be 2 or 4 characters.
• Examples of acceptable dating
• 12-Feb-2016
• 12Feb16
• 02Dec16
 Data Consistency
Time Entry
• Time entry must be noted to differentiate between AM and
PM
• Noon = 12:00 PM
• Midnight = 12:00 AM
Numeric Data Entry
• All units of measure must be identified with the appropriate
unit of measure. For example:
• Pressure in psi or mmHg
• Temperature in Degrees C or F
• Weights in mg, g, kg, etc.
• Length in inches (unless otherwise specified )
 Changes/Errors/Corrections

All corrections should be made as follows:

• Never erase/obliterate (blotting out) an entry To correct errors
• Draw a single, continuous, straight line through the error or
information to be changed. The original information must
remain legible.
• Always initial and date the cross out.
• Write the required correction or change adjacent to or as close
as possible to the changed text.
• When changes or corrections are made on approved
documents, it must go through the EC process.
Documentation/Record Keeping Don’ts
• DO NOT scribble out mistakes (obscures entry)
• Single line, initial and date the error.
• DO NOT write correct entries over top of incorrect entries
(write-overs obscure original entries)
• DO NOT forget to enter all required info including revisions of
reference documents being used.
• If information is omitted from original entry, a late entry may
be made, initialed and dated.
• DO NOT forget to initial and date entry
• DO NOT leave mistakes uncorrected (check your entries)
• DO NOT leave empty or blank spaces (mark all empty or blank
spaces with a line, ‘N/A’, or “grayed-out” with respect to
electronic documents)
Documentation/Record Keeping Don’ts
• Backdating nor Postdating Entries
• Erasable Ink
• White-Out
• Incomplete Copies
• Signing using another associate’s name
• Unapproved functions or unauthorized signatures
• Not recording calculations
• Not maintaining traceability
• Incomplete copies
• Discarding raw data
 Summary
• Good Documentation Practices does take time, commitment
and attention to detail.
• The time spent doing the task correctly the first time will
prevent, or at least minimize, time-consuming and costly
reviews, corrections, and time/money involved in repeating
work conducted incorrectly.
• Ultimately the most dangerous price for poor documentation is
non-compliance which could have devastating effects on the
company, product, your employment, and other people’s lives.
• Good Documentation Practices are EVERYONE’S and YOUR
Responsibility.
Questions
Please direct any questions to quality management.
Thanks for your continued support in this very critical matter.
TRN-NMD-0018-00 Document Change Record
Document Revision EC Number EC Effective Date
01 EC-NMD-3000 19 July 2018